Senior Associate, Regulatory Affairs CMC
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
By providing a foundation for all operations company wide, BioMarin’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.
Regulatory Affairs Senior Associate works with the Regulatory Affairs Associate Director to ensure that the activities that take place and the documentation that is produced within the cGMP environment comply with the necessary regulations and guidelines governing the development, licensure and marketing of drugs and/or biologics to fulfil project objectives.
The Regulatory Affairs CMC Senior Associate reports to the Regulatory Affairs CMC Associate Director.
Conduct relevant checks to support regulatory CMC queries from various groups across site,
Process GMP documentation to support global submissions.
Responsible for the timely sourcing and or authoring of documentation to support regulatory submissions worldwide
Assist in the preparation for interactions with global regulatory authorities
Represent regulatory cmc at relevant site meetings
Participate in global teams as regulatory cmc representative for project specific discussions
Responsible for timely sourcing and or authoring of documentation to support regulatory filings and/or correspondence with Regulatory bodies.
Proactively identifying issues and suggesting appropriate strategies to mitigate risks.
Ensure consistent and appropriate communication within the department and with other functional areas.
Interact with global Regulatory partners, internal cross functional teams, and consultants.
Participate in cross-functional project teams and work effectively with multiple disciplines and personalities
5+ years experience in a cGMP regulated environment, with exhibited knowledge or proficiency in CMC Regulatory Affairs or a related function.
Candidate should demonstrate initiative and have the ability to work both independently and collaboratively in a team structure.
Demonstrated effective problem solving, strong understanding of regulatory affairs submission and management skills and the ability to prioritize multiple tasks are also required
Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.